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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001431-31 | EudraCT Number |
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The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8 weeks | Experimental |
| |
| 12 weeks | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT-527 | Drug | Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving sustained virologic response (SVR) | SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment | 12 weeks after end of treatment |
| Incidence of treatment-emergent adverse events | Through 4 weeks after end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao-Jian Zhou, PhD | Atea Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Antwerp | Belgium | ||||
| Clinical Trial Site |
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Subjects will receive 8 or 12 weeks of treatment, based on treatment response.
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| Daclatasvir | Drug | Inhibitor of HCV nonstructural protein 5A (NS5A) |
|
| Phoenix |
| Mauritius |
| Clinical Trial Site | Chisinau | Moldova |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000713067 | AT-511 |
| C549273 | daclatasvir |
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